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Letrozole and Temozolomide for Recurrent Gliomas

This study is looking at letrozole, a drug given by mouth, in people with recurrent high-grade glioma (a type of brain tumor). The main goal is to see how much letrozole gets into the tumor. Researchers are also studying how well letrozole combined with temozolomide (another oral drug) helps prevent the tumor from growing for at least 6 months. You may be able to join if you are over 18, have a recurrent high-grade glioma confirmed by imaging or biopsy, and have a good performance status (meaning you can mostly care for yourself). The main part of this study has finished enrolling, but a new sub-study combining letrozole and temozolomide is currently enrolling about 17 new participants.

Study design
This is an interventional study, meaning participants receive a specific treatment. It is a Phase 1 expansion cohort, enrolling a total of 19 subjects (including 2 from a previous part of the study and 17 new participants).
What's involved
Letrozole will be given orally once daily. Temozolomide will be given orally once daily at 50 mg/m2.
Compensation
Not stated in the trial record.
Follow-up
Progression-free survival will be measured at 6 months.

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NCT03122197

Study of Letrozole in Recurrent Gliomas

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Cincinnati
~39 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Letrozole Oral TabletTemozolomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Letrozole AUC in tumor tissue.
Measured over 5 days
+1 more outcome measured

Conditions

Brain Tumor

Explore related trials

Malignant Glioma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Lalanthica Yogendran, MD · PRINCIPAL_INVESTIGATOR · University of Cincinnati

Who to contact

UC Cancer Center Clinical Trials Office
[email protected]
513-584-7698
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3;
Platelets ≥ 100,000 cells/mm3;
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable). 5. Adequate hepatic function, defined as follows:
Total bilirubin \< 2 x institutional ULN within 14 days prior to registration;
AST or ALT \< 3 x institutional ULN within 14 days prior to registration. 6. Adequate renal function, defined as GFR \> 30 ml/min or Cr \< 1.5. 7. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. 8. Imaging prior to treatment including MRI of brain (with contrast preferred but not required). 9. Ability to understand and the willingness to sign a written informed consent document.

What this trial measures

  • Overall Letrozole AUC in tumor tissue.5 days

    Pharmacokinetic modeling will be used to determine the overall AUC in the tumor tissue to assess for letrozole penetration through blood brain barrier.

  • Progression free survival in letrozole and temozolomide combination6 months

    Sub-study expansion cohort only: Progression free survival using RANO criteria at 6 months from the start of the combination of 15 mg letrozole and 50 mg/m2 temozolomide.